Cryoablation surgery is used successfully to treat certain forms of cancer, complex arrhythmias and other medical afflictions. During a cryoablation procedure, a cryo-catheter is inserted into the vasculature of a patient for cryo-ablating diseased tissue. Successful cryoablation surgery requires that the portion of the cryo-catheter in contact with the diseased tissue, referred to as the “tip”, is cooled to temperatures on the order of −20° C. to −80° C. To achieve these extremely low temperatures, cryoablation systems introduce a fluid refrigerant into an expansion chamber in the tip. Functionally, the fluid refrigerant expands in the chamber. The resultant heat transfer cools the tip, and the expanded refrigerant is then exhausted from the chamber through a return line. Typically, a supply line is connected to a source of the fluid refrigerant, and is used for transferring refrigerant from the source to the expansion chamber. Further, a vacuum source is connected in fluid communication with a return line for evacuating the expanded refrigerant from the expansion chamber. For patient safety and for system efficiency, the low temperatures that are generated must be confined to the tip, and the refrigerant must be contained within an “air tight” cryo-catheter. Further, it will be appreciated that if the efficient flow of fluid refrigerant through a cryo-catheter is impeded or otherwise altered, the cryoablation catheter cannot be used effectively for its intended purpose.
Several factors may contribute to the inefficient flow of a liquid refrigerant through a cryoablating system. For example, the failure to maintain adequate flow may result from either a leak or an occlusion in the system. Under proper conditions, a leak would be indicated by a loss or reduction of the partial vacuum induced by the vacuum source. On the other hand, an occlusion would be indicated by an increased pressure at the cryo-catheter tip. In either case, i.e. a system failure resulting from either a leak or an occlusion, the system cannot achieve the required tip temperatures and the cryoablation procedure should be stopped.
During the course of a cryoablation procedure, a test for leaks and occlusions in the cryoablation system may be performed prior to inserting the catheter tube into the patient. It may be desirable, however, that the test be performed in-vivo. If so, the reliability and brevity of the test procedure are all the more critical. During an in-vivo check of the fluid integrity of a cryoablation system, a physical inspection of the components of the cryo-catheter is not possible. Therefore, the methods used to evaluate the fluid integrity of the system, in-vivo, must infer the status of the system from measured data.
For a given cryoablation catheter, the dimensions of the catheter tube are well defined (e.g. length, inner and outer diameters, volume). Also well defined (i.e. controlled) are the input pressure of the fluid refrigerant, as well as the level of partial vacuum required to evacuate the catheter tube. By knowing the dimensions of the catheter tube, the input pressure of a fluid as it is introduced into the tube, and vacuum level as fluid is being evacuated from a tube, it is possible to predict with a high degree of accuracy the consequent pressure at points within a cryoablation system. This ability to predict, however, assumes the catheter is both “air tight” and patent. Consequently, variations from predicted pressures can be indicative of a compromise in the fluid integrity of the system.
In light of the above, it is an object of the present invention to provide a system for detecting leaks and occlusions in a cryoablation catheter. Another object of the present invention is to provide a system for detecting leaks and occlusions in a cryoablation catheter wherein a tip pressure, “pt”, can be measured in a cryoablation chamber and used to verify the fluid integrity of the system during cryoablation surgery. Still anther object of the present invention is to provide a system for detecting leaks and occlusions in a cryoablation catheter wherein the verification of fluid integrity may be reliably and quickly performed in-vivo, without jeopardizing the health and safety of the patient. Yet another object of the present invention is to provide a system for detecting leaks and occlusions in a cryoablation catheter that is relatively easy to manufacture, is simple to use and is comparatively cost effective.